21 C.F.R. § 524.1195
Ivermectin otic suspension.
Cite as 21 C.F.R. § 524.1195 (2026)
(a)
Specifications.
Each tube contains 0.5 milliliter (mL) of a 0.01 percent suspension of ivermectin.
(b)
Sponsor.
See No. 000010 in § 510.600(c) of this chapter.
(c)
Conditions of use
—(1)
Amount.
Administer the contents of one 0.5-mL tube topically into each external ear canal.
(2)
Indications for use.
For the treatment of adult ear mite (
Otodectes cynotis
) infestations in cats and kittens 4 weeks of age and older. Effectiveness against eggs and immature stages has not been proven.
(3)
Limitations.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[66 FR 7578, Jan. 24, 2001, as amended at 74 FR 26782, June 4, 2009]
- Cross-references to the CFR
- 510.600